坎地沙坦酯左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.971709751714801714141713281714121713220.12
215.951715121721891718500.28
单位质量响应值RSD%判断
10727.7410774.290.31数据可信
影响因素30天-供试品溶液-2024042711批-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min120601-2060110.75712.3316.3410.7612.3316.32
228370-2837014.81414.81
317673-176739.2289.23
426008-2600813.58013.58
524439-2443912.76112.76
624613-2461312.85212.85
10min151289-5128926.78128.688.6126.9028.828.64
260689-6068931.69031.85
347802-4780224.96025.06
458181-5818130.38030.53
554739-5473928.58328.72
656867-5686729.69429.84
15min175390-7539039.36641.086.0739.7841.546.12
284661-8466144.20744.72
371524-7152437.34737.73
482544-8254443.10143.59
578288-7828840.87941.34
679656-7965641.59342.07
20min193150-9315048.63951.234.7349.4952.144.79
2101979-10197953.25054.26
392142-9214248.11348.91
4103636-10363654.11555.08
598356-9835651.35852.27
699376-9937651.89052.83
30min1121614-12161463.50264.723.2364.9066.203.30
2129216-12921667.47269.07
3118781-11878162.02363.35
4127599-12759966.62768.20
5121591-12159163.49064.97
6124900-12490065.21866.73
45min1141496-14149673.88475.031.1275.9877.231.22
2146014-14601476.24378.59
3142486-14248674.40176.42
4143728-14372875.04977.36
5144757-14475775.58777.78
6143629-14362974.99877.23
60min1158287-15828782.65282.341.9185.5785.371.96
2162099-16209984.64287.84
3154527-15452780.68883.53
4160072-16007283.58486.73
5156051-15605181.48484.51
6155088-15508880.98184.05
极限1162981-16298185.10384.841.8788.9488.791.90
2167176-16717687.29391.43
3160903-16090384.01787.76
4164605-16460585.95190.02
5159809-15980983.44687.38
6159378-15937883.22187.19
坎地沙坦酯左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.971711301708961707961706011708761708600.12
215.951715971722021719000.25
单位质量响应值RSD%判断
10698.8110777.430.52数据可信
影响因素30天-供试品溶液-2024042711批-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min121238-2123811.10312.3812.0311.1012.3812.02
225508-2550813.33513.34
322644-2264411.83811.84
420803-2080310.87610.88
528356-2835614.82414.82
623520-2352012.29612.30
10min153493-5349327.96629.034.9728.0929.175.00
257638-5763830.13330.28
354413-5441328.44728.58
451885-5188527.12527.25
559268-5926830.98531.15
656482-5648229.52829.67
15min175919-7591939.69041.402.8440.1241.862.87
282418-8241843.08843.57
378802-7880241.19741.64
478281-7828140.92541.35
580906-8090642.29742.81
678834-7883441.21441.68
20min196232-9623250.31051.351.7951.1852.261.82
2100616-10061652.60153.56
397647-9764751.04951.95
496560-9656050.48151.36
598401-9840151.44352.42
699831-9983152.19153.11
30min1122214-12221463.89365.282.0765.3366.772.03
2125770-12577065.75267.30
3125315-12531565.51466.99
4124243-12424364.95466.39
5122459-12245964.02165.57
6129214-12921467.55269.05
45min1144722-14472275.66076.921.8977.8079.141.87
2149204-14920478.00380.28
3147661-14766177.19679.40
4146665-14666576.67678.84
5143560-14356075.05277.31
6151022-15102278.95381.21
60min1157454-15745482.31682.571.7285.3085.641.68
2160502-16050283.90987.05
3158419-15841982.82185.88
4157670-15767082.42985.44
5153127-15312780.05483.15
6160442-16044283.87887.01
极限1166565-16656587.07986.041.4990.9890.021.42
2165842-16584286.70190.78
3162683-16268385.05089.03
4166406-16640686.99690.92
5160483-16048383.90087.88
6165426-16542686.48490.55
坎地沙坦酯左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.971721251720091719781722871723041721410.09
215.951713091716311714700.14
单位质量响应值RSD%判断
10779.0210750.470.19数据可信
影响因素30天-供试品溶液-2024042711批-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min126385-2638513.76014.7512.6213.7614.7512.63
230963-3096316.14716.15
324700-2470012.88112.88
433553-3355317.49817.50
529227-2922715.24215.24
624908-2490812.98912.99
10min162938-6293832.82233.385.1532.9733.545.19
266288-6628834.56934.75
361653-6165332.15232.29
469440-6944036.21336.41
563176-6317632.94633.12
660516-6051631.55931.70
15min185665-8566544.67446.622.8245.1947.162.85
291873-9187347.91148.47
388299-8829946.04746.55
492294-9229448.13148.73
590083-9008346.97847.51
688175-8817545.98346.48
20min1105508-10550855.02256.672.5556.0457.722.59
2111354-11135458.07159.17
3108336-10833656.49757.51
4112322-11232258.57559.71
5108521-10852156.59357.65
6105932-10593255.24356.25
30min1133868-13386869.81170.080.8871.4471.760.94
2134269-13426970.02171.76
3133004-13300469.36171.00
4136558-13655871.21473.00
5134257-13425770.01471.70
6134320-13432070.04771.67
45min1154472-15447280.55680.100.7982.9682.560.79
2151729-15172979.12681.64
3153621-15362180.11382.52
4155176-15517680.92383.50
5153749-15374980.17982.64
6152867-15286779.71982.12
60min1162141-16214184.55684.010.4887.8587.360.44
2160924-16092483.92187.32
3161551-16155184.24887.55
4160488-16048883.69487.17
5161399-16139984.16987.52
6160031-16003183.45586.74
极限1165158-16515886.12985.731.4290.3690.021.29
2164414-16441485.74190.07
3164089-16408985.57289.81
4161864-16186484.41188.81
5162452-16245284.71889.01
6168412-16841287.82692.04
坎地沙坦酯左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.971726721728691728861727311728011727920.06
215.951739241740851740040.07
单位质量响应值RSD%判断
10819.7910909.340.59数据可信
影响因素30天-供试品溶液-2024042711批-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min124838-2483812.83414.7515.8212.8314.7515.82
234604-3460417.88017.88
327050-2705013.97713.98
427282-2728214.09714.10
533627-3362717.37517.38
623875-2387512.33612.34
10min160652-6065231.34032.995.8531.4833.155.90
269279-6927935.79736.00
362776-6277632.43732.59
464126-6412633.13533.29
566822-6682234.52834.72
659397-5939730.69130.83
15min184636-8463643.73245.663.3344.2246.193.39
292819-9281947.96148.56
387399-8739945.16045.68
488265-8826545.60846.13
590600-9060046.81447.39
686498-8649844.69545.17
20min1102441-10244152.93254.982.3753.9156.022.42
2109079-10907956.36257.49
3105956-10595654.74955.77
4105589-10558954.55955.59
5109193-10919356.42157.52
6106183-10618354.86655.84
30min1131923-13192368.16668.471.1569.7370.121.18
2134892-13489269.70071.46
3131197-13119767.79169.42
4130999-13099967.68969.33
5132344-13234468.38470.11
6133755-13375569.11370.70
45min1150921-15092177.98378.480.9580.3080.881.01
2154615-15461579.89182.42
3150606-15060677.82080.20
4151870-15187078.47380.86
5151941-15194178.51080.99
6151312-15131278.18580.54
60min1160853-16085383.11582.961.0286.3086.240.99
2162399-16239983.91387.33
3158618-15861881.96085.20
4160458-16045882.91086.17
5158762-15876282.03485.39
6162223-16222383.82287.04
极限1166194-16619485.87484.911.0789.9989.111.01
2164799-16479985.15489.50
3163266-16326684.36188.52
4161767-16176783.58787.77
5163683-16368384.57788.84
6166204-16620485.88090.03
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